Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm

FDA 510(k) K150518 · Dupaco, Inc.

Substantially Equivalent

510(k) numberK150518

Submission

Device name
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
Applicant
Dupaco, Inc.
Oceanside, CA, US
Received
March 2, 2015
Decision date
June 29, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXL – Block, Bite
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5070
Specialty
Neurology

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K172978SurgeoBiteJXL · Traditional Surgovations, LLC12/22/2017SE
K050188EpiguardJXL · Traditional Episafe Medical Devices, Ltd.04/27/2005SE
K992269Ventil-A Oral ProtectorJXL · Traditional Somatics, Inc.10/25/1999SE
K960663Universal Bite BlockJXL · Traditional B&B Medical Technologies, Inc.05/17/1996SE
K954352Bite BlockJXL · Traditional United States Endoscopy Group, Inc.01/25/1996SE
K941856Premier Promax Bite GuardJXL · Traditional Premier Dental Products Co.04/05/1995SE
K924333The Davis Disposable Protective SplintJXL · Traditional Ora-Gard, Inc.04/23/1993SE
K924304Bite BlockJXL · Traditional United States Endoscopy Group, Inc.04/06/1993SE

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K821434EKG (ECG) ElectrodesDRX · Traditional 07/30/1982SE
K770084Operating Room VentilatorFZH · Traditional 02/23/1977SE

Questions and answers

When was Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm cleared by the FDA?

Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm (K150518) received a 510(k) decision of Substantially Equivalent on June 29, 2015, 119 days after the submission was received.

What is the product code of K150518?

The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.